Engineer I, QA

Job Description :

Work Schedule

Environmental Conditions

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

REQUIREMENTS:

• Bachelor's Degree required
• Preferred Fields of Study: Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
• Additional certifications in Quality Systems or GMP preferred
• Strong knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements
• Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
• Proficiency in quality management software systems (TrackWise, SAP, OCPLM, etc)
• Demonstrated ability to perform detailed documentation review and quality assessments
• Strong analytical and problem-solving skills for quality investigations and root cause analysis
• Excellent written and verbal communication skills
• Ability to work independently and collaborate effectively with cross-functional teams
• Proficient computer skills including Microsoft Office applications
• Strong attention to detail and commitment to accuracy
• Ability to prioritize and adapt in a changing environment
• Good knowledge of using AI Tools and/or programming macros preferred